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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Cancer Cell Therapy Trials Spike in Last Six Months, New Report Finds

In just the six months from last September to March, the number of cancer cell therapies in development has increased by 87%, though about half of the total tallied is in the preclinical phase, according to a new report from the non-profit Cancer Research Institute in Nature Reviews Drug Discovery.

The Cancer Research Institute’s database is now tracking 753 cell therapies, pursuing 113 different targets, and of which 375 are in clinical trials and 378 are in the preclinical phase.

The US and China are developing more than two-thirds of the cancer cell therapies, and one third in the database are being developed by academic centers in both countries.

The cell therapies were classified into seven categories based on the mechanism of action:

“Most of the CAR T [chimeric antigen receptor T-cell] agents developed in China are not innovative therapies, but locally produced agents with properties similar to those already approved or in late stage clinical development in the US,” the article says.

And three cell and gene therapies have won FDA approval: two Car-T cell therapies, including Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL) and Gilead’s Yescarta (axicabtagene ciloleucel) for adults with certain types of large B-cell lymphoma; and a new gene therapy from Spark Therapeutics for the treatment of children and adult patients with an inherited form of vision loss that may result in blindness.

Earlier this week, FDA Commissioner Scott Gottlieb discussed several new cell and gene therapy guidance documents that are expected soon.

Gottlieb also said the agency may be willing to accept more uncertainty for certain gene and cell therapies, particularly with those earning the new Regenerative Medicine Advanced Therapy (RMAT) designation. He noted that as of the end of April, there had been 62 RMAT designation submissions since the inception of the program in December 2016, and 19 designations have been granted (see 16 of them here).